NCT00365287

Brief Summary

RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer, metastatic breast cancer, or kidney cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Jun 2000

Typical duration for phase_1 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

5.5 years

First QC Date

August 16, 2006

Last Update Submit

November 27, 2017

Conditions

Breast CancerKidney CancerLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage IV breast cancerrecurrent renal cell cancerstage III renal cell cancerstage IV renal cell canceradult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiaaccelerated phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrefractory anemiaadult acute lymphoblastic leukemia in remissionblastic phase chronic myelogenous leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood chronic myelogenous leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent adult acute lymphoblastic leukemiarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemiarefractory multiple myelomasecondary acute myeloid leukemiasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarefractory anemia with excess blasts in transformationrefractory anemia with ringed sideroblastsrefractory cytopenia with multilineage dysplasiarefractory anemia with excess blastschildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Safety as assessed by a non-relapse mortality < 30% within day 100

Secondary Outcomes (1)

  • Hematopoietic recovery and the degree of chimerism at days 21, 60, 100, 180, and 360 after study completion

Interventions

anti-thymocyte globulinDRUG
cyclophosphamideDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
radiation therapyPROCEDURE
umbilical cord blood transplantationPROCEDURE

Eligibility Criteria

AgeUp to 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * In first complete remission (CR1) by morphology AND at high risk, as evidenced by 1 of the following: * AML secondary to myelodysplastic syndromes (MDS) * High-risk cytogenetics, such as those associated with MDS or complex karyotype * More than 2 courses of therap were required to obtain a CR * In second or greater CR by morphology * In morphologic relapse or persistent disease, defined as \> 5% blasts in normocellular bone marrow OR any percentage of blasts if blasts have unique morphologic markers (e.g., auer rods) * In cytogenetic relapse (without morphologic relapse) * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * In CR1 by morphology AND at high risk, as evidenced by 1 of the following: * High-risk cytogenetics, such as t(9;22), t(1;19), t(4;11), or other MLL rearrangements * More than 1 course of therapy was required to obtain a CR * In second or greater CR by morphology * In morphologic relapse or persistent disease as defined for AML * In cytogenetic relapse (without morphologic relapse) * Chronic myelogenous leukemia * All types allowed except refractory blast crisis * Non-Hodgkin's lymphoma (NHL) * No intermediate- or high-grade NHL or mantle cell NHL that is progressive on salvage therapy * Stable disease allowed provided it is non-bulky * Hodgkin's lymphoma * No progressive disease on salvage therapy * Stable disease allowed provided it is non-bulky * Chronic lymphocytic leukemia * Multiple myeloma * MDS * Any subtype allowed, including refractory anemia if there is severe pancytopenia or complex cytogenetics * Less than 5% blasts * If patient has blasts ≥ 5% then they must undergo induction therapy before transplantation * Metastatic breast cancer * Disease must have responded to recent chemotherapy OR in plateau after response to chemotherapy * Renal cell cancer * Acquired bone marrow failure syndromes * Small percentage of blasts that is equivocal between marrow regeneration vs early relapse allowed provided there are no associated cytogenetic markers consistent with relapse (for patients with AML or ALL) * Must have a 4/6 HLA-A, -B, and -DRB1 matched unrelated umbilical cord blood donor available * No 5/6 or 6/6 HLA-A , -B, and -DRB1 matched sibling donor available * No more than 2 antigen mismatches at the HLA-A, -B, or -DRB1 loci NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% OR Lansky performance status 50-100% (pediatric patients) * Albumin \> 2.5 g/dL * Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance \> 40 mL/min (pediatric patients) * Adults with creatinine \> 1.2 mg/dL or a history of renal dysfunction must have a creatinine clearance \> 40 mL/min * Transaminases \< 5 times upper limit of normal (ULN) * Bilirubin \< 3 times ULN * LVEF ≥ 35% * DLCO \> 30% of predicted * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No evidence of HIV infection or known HIV-positivity * No decompensated congestive heart failure * No uncontrolled cardiac arrhythmia * No requirement for supplemental oxygen * No active, serious infection * Recent mold infection (e.g., Aspergillus) allowed provided patient has received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by an infectious disease specialist PRIOR CONCURRENT THERAPY: * No prior irradiation that precludes the safe administration of 1 additional dose of 200 cGy of total-body irradiation * At least 3 months since prior myeloablative bone marrow transplantation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Bachanova V, Burke MJ, Yohe S, Cao Q, Sandhu K, Singleton TP, Brunstein CG, Wagner JE, Verneris MR, Weisdorf DJ. Unrelated cord blood transplantation in adult and pediatric acute lymphoblastic leukemia: effect of minimal residual disease on relapse and survival. Biol Blood Marrow Transplant. 2012 Jun;18(6):963-8. doi: 10.1016/j.bbmt.2012.02.012. Epub 2012 Mar 16.

    PMID: 22430088DERIVED

  • Bachanova V, Sandhu K, Yohe S, Cao Q, Burke MJ, Verneris MR, Weisdorf D. Allogeneic hematopoietic stem cell transplantation overcomes the adverse prognostic impact of CD20 expression in acute lymphoblastic leukemia. Blood. 2011 May 12;117(19):5261-3. doi: 10.1182/blood-2011-01-329573. Epub 2011 Mar 14.

    PMID: 21403127DERIVED

  • Bachanova V, Verneris MR, DeFor T, Brunstein CG, Weisdorf DJ. Prolonged survival in adults with acute lymphoblastic leukemia after reduced-intensity conditioning with cord blood or sibling donor transplantation. Blood. 2009 Mar 26;113(13):2902-5. doi: 10.1182/blood-2008-10-184093. Epub 2009 Jan 28.

    PMID: 19179301DERIVED

MeSH Terms

Conditions

Breast NeoplasmsKidney NeoplasmsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesCarcinoma, Renal CellCongenital AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseHodgkin DiseaseRecurrenceLeukemia, Lymphocytic, Chronic, B-CellAnemia, RefractoryBlast CrisisLymphoma, B-Cell, Marginal ZonePrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, FollicularLymphoma, Mantle-CellAnemia, Refractory, with Excess of Blasts

Interventions

Antilymphocyte SerumCyclophosphamideCyclosporinefludarabine phosphateMycophenolic AcidRadiotherapyCord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, LymphoidAnemiaCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsTherapeuticsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • Claudio G. Brunstein, MD, PhD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

June 1, 2000

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

November 29, 2017

Record last verified: 2017-11